Acute Subdural Hematoma
ConditionTrauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMethodist Health System
About this trial
This retrospective data repository will serve as a means to aggregate and analyze standard surgical interventions and Middle Meningeal Arteryembolization as suitable treatment options for Acute Subdural Hematoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Included in the Methodist Dallas Medical Center Trauma Registry
Acute subdural hematoma identified on computed tomography scan or magnetic resonance imaging of the brain in the trauma bay within 72 hours of a traumatic event
Disqualifiers
<18 years old
Prisoners, pregnant persons, or other protected population
Trial population
Acute subdural hematoma, a consequential manifestation within 72 hours post-trauma, is a major cause of morbidity and mortality following severe traumatic brain injury. In patients where Acute subdural hematoma is accompanied by progressive neurologic deficits or substantial mass effect, prompt surgical intervention via craniotomy or decompressive craniectomy serves as the standard approach to mitigate the risk of further morbidity and mortality.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Medical/Phenotype Data Collection Procedures & Data to be Collected
Other interventionTheMethodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Total Number and Description of Study Sites/Total Number of Subjects1 intervention
Trial outcomes
Primary outcomes
1
Total Number of Study Sites
This study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. We anticipate 5 years of data to be captured (January 2018 through December 2023).
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov